sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur
Generic: SULFACETAMIDE SODIUM AND SULFUR
Basic Information
Manufacturer
Allegis Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1aa1025f-c568-34d3-e063-6394a90a37b8
Indications & Usage
INDICATIONS Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings
WARNINGS Although rare, sensitivity to sodium sulfacetamide may occur.
Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides.
Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides.
Particular caution should be employed if areas of denuded or abraded skin are involved.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Avoid contact with eyes, lips and mucous membranes.
KEEP OUT OF REACH OF CHILDREN.
Keep container tightly closed.
Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides.
Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides.
Particular caution should be employed if areas of denuded or abraded skin are involved.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Avoid contact with eyes, lips and mucous membranes.
KEEP OUT OF REACH OF CHILDREN.
Keep container tightly closed.
Adverse Reactions
ADVERSE REACTIONS Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon.
The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS ).
Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS or obtain product information, contact Allegis Pharmacuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS ).
Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS or obtain product information, contact Allegis Pharmacuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.